QA Manager

OMIC USA Inc.•Portland, OR

3d•Onsite

About The Position

Quality Assurance Manager verifies the quality, policies, and regulatory compliance in the laboratory to achieve the Company’s mission and objectives. This role is responsible for coordinating and maintaining the laboratory’s Quality Management System, ensuring internal audits are performed, preparing reports for regulatory agencies, verifying new method validations, writing and maintaining SOPs, performing procedural audits, making reports on laboratory performance, coordinating Annual Quality Review Meetings, managing equipment calibration, assisting with sales and marketing QA inquiries, and conducting training for laboratory personnel. The position also manages the QA Associate/Assistant position(s) and carries out supervisory responsibilities in accordance with the organization's policies and applicable laws, including interviewing, hiring recommendations, training, planning, assigning work, and appraising performance.

Requirements

Bachelor's degree (B.S.) in Chemistry or relevant science from a four-year college or university.
Previous laboratory experience preferred.
2 years QA experience in regulatory compliance, preferably ISO 17025, NELAC and/or GLP; or equivalent combination of education and experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write SOPs, reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from subordinates, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to perform standard quality assurance / quality control evaluation procedures, including audits.
Technical writing for preparing manuals and documentation.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Familiar with the laboratory business environment.
Successful experience of collaborating with different business departments.
Demonstrated successful experience of leading, motivating, and supervising teams of relevant significance.
Demonstrated experience of successful change management of relevant complexity.
Connected well with relevant external organizations and good knowledge of the industry best practice.
Experience working in international businesses and a good cultural awareness.
Excellent interpersonal skills.
Strong analytical and problem-solving skills.
Excellent in other OMIC’s performance factors.
Highly competent user of MS Office.

Nice To Haves

Registered Quality Assurance Professional (RQAP)
Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)
Laboratory analytical experience

Responsibilities

Be a proactive leader; identify opportunities and foster a culture of continual improvement of quality and procedures in the laboratory.
Coordinate and maintain the laboratory’s Quality Management System with support from the Laboratory Director, Laboratory Manager, Group leaders, and laboratory staff including: Document Control and Quality Records, Training Documentation, Internal and External Audits, Corrective & preventative actions, and continuous improvement, Proficiency testing; scheduling, reporting & follow up, Supplier qualification, and traceability, Archivist for GLP study specific records.
Ensure internal audits of the quality management system are performed at least once a year to maintain compliance with the appropriate standards and accreditation programs and identify areas of non-conformance and/or areas for improvement.
Prepare special reports to regulatory agencies and/or clients; for example – summary reports of analytical results, external audit responses, FDA data packages, and ODA data packages.
Verify new method validations and improvements are in compliance with OMIC’s policies as well as regulatory requirements.
Write and maintain quality management system SOPs and documentation in collaboration with other members of the QAU, Laboratory Manager, Laboratory Director, and other relevant departments. Coordinate and/or complete review of other controlled laboratory documentation for compliance and quality.
Perform procedural audits of methods conducted in the laboratory against the appropriate SOPs, LABs, and regulatory requirements to ensure accuracy of procedural documentation and adherence to laboratory procedures.
Make periodic reports to the Laboratory Manager and Director as to the quality of the laboratory’s performance and audit details (observations, findings, non-compliances, and non-conformances). Make recommendations as on necessary steps to be taken to ensure improvements.
Coordinate Annual Quality Review Meetings with Laboratory Management, compile the necessary data/information throughout the year and prepare the annual Management Review of the Quality System Report.
Coordinate and manage the verification and/or maintenance of scheduled calibration of laboratory support equipment.
Assist with sales and marketing to existing and potential clients on QA related enquiries.
Coordinate and conduct laboratory meetings with personnel to communicate information on laboratory operations, regulatory updates, quality improvements, and quality issues.
Coordinate and conduct quality assurance training for laboratory personnel.
Manages the QA Associate/Assistant position(s). Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, make recommendation for hiring, training new employees; planning, assigning, and directing work; appraising performance.